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Идёт набор NCT05598879

Global Cardio Oncology Registry

Наблюдательное Breast Cancer Hematologic Malignancy Immune Checkpoint Inhibitor-Related Myocarditis Cardiotoxicity

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: anonymized data collection during programmed surveillance clinical follow up.
Кому может быть актуально
Состояния в реестре: Breast Cancer, Hematologic Malignancy, Immune Checkpoint Inhibitor-Related Myocarditis, Cardiotoxicity. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

G-COR is the first Global Prospective Cardio-Oncology Registry. It is a multinational, multicenter prospective observational cohort registry, with the goal of collecting clinical, laboratory, imaging, demographic, and socioeconomic data to identify risk factors associated with increased incidence of cancer therapy related cardiovascular toxicity (CTR-CVT) in different settings and to derive and validate risk scores for cardio oncology patients treated in different geographic locations throughout the world.

Подробное описание

G-COR is the first Global Prospective Cardio-Oncology Registry. It is a multinational, multicenter prospective observational cohort registry, with the goal of collecting clinical, laboratory, imaging, demographic, and socioeconomic data to identify risk factors associated with increased incidence of cancer therapy related cardiovascular toxicity (CTR-CVT) in different settings and to derive and validate risk scores for cardio oncology patients treated in different geographic locations throughout the world.

G-COR will involve the collaboration from 124 hospitals from 24 countries that completed survey with sites demographics. It will evaluate cardiovascular disease in three distinct populations of cancer patients (hematological malignancies: lymphomas, leukemias, multiple myeloma; breast cancer patients; and patients treated with check point inhibitors immunotherapy).

G-COR will evaluate the cardiovascular impact of different cancer treatments in the above-described patients, and similarities and differences in diagnostic and treatment modalities as well as outcomes and the impact of socioeconomic factors and risk factors for toxicities in a large worldwide population.

G-COR will study the impact of cancer in CV disease in cancer patients treated at academic centers as well as in patients treated at community hospitals, through a systematic prospective data collection in a global digital platform.

G-COR is an IRB approved prospective registry, conducted with the logistical support of C5 Clinical Research Division and the Cardiovascular Outcomes Registries and Research (CORR) group at the Cleveland Clinic and have developed eCRFs with an extensive Red Cap Cloud platform.

G-COR Executive, Scientific and topic committees are led by North American, European, Latin American, Australian and Asian representatives from both academic and community centers.

G-COR Pilot US, was completed (phase 1) with breast cancer patients from 18 US Centers and enrolled 700 patients.

G-COR Global Phase 2, has now started enrolling patients from the three pillars (-breast cancer, -hematological malignancies, and -patients treated with immune check point inhibitors (ICI). Enrollment of phase 2 started in early 2026 and will continue with enrollment and follow up until July 2029.

G-COR Global International will start in 2026 with centers from Europe, Latin America, Australia, Asia and Africa.

Вмешательства

  • Другое anonymized data collection during programmed surveillance clinical follow up
    anonymized data entry of demographic, clinical, imaging, laboratory, cancer treatment, and cardiovascular events into a RedCap Cloud platform

Первичные конечные точки

  • Cardiotoxicity [Срок оценки: 18 months of prospective follow up]
  • New cardiovascular events [Срок оценки: 18 months of prospective follow up]
  • Cardiovascular death. [Срок оценки: 18 months of prospective follow up]

Критерии участия

Критерии включения

  • New cardio-oncology consultation for breast cancer patients, or
  • New cardio-oncology consultation for Hodgkin's or non-Hodgkin's lymphoma patients, or
  • New cardio-oncology consultation for acute or chronic leukemia patients, or
  • New cardio-oncology consultation for multiple myeloma or AL amyloidosis, or
  • New cardio-oncology consultations for immune check-point inhibitors cardiac evaluation.
  • All patients have to be 18 years old or older

Критерии исключения

  • Cardio-oncology patients who have previously had cardio-oncology evaluation and follow up by the investigators.
  • Minors less than 18 years old.
  • Inability or unwillingness to consent to participate

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

США · 1 центр
  • Cleveland Clinic Florida — Weston

Идентификаторы

NCT: NCT05598879 · IRB 22-211

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗